Corona COVID-19
Conditions
Interventions
- Hydroxychloroquine 200 mg or
- Placebo
Day 1: 4 capsules hydroxychloroquine or placebo, then 2 units
hydroxychloroquine or placebo 6-8 hours later
Days 2-10: 1 capsule hydroxychloroquine or placeb
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Participants * 18 years and * 80 years of age - Participants with a diagnosis of COVID-19 via an approved or authorized molecular test - Presence of symptoms compatible with COVID-19 at the time of screening - Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less - Female participants must use an acceptable birth control method, as specified by each site and country
Exclusion criteria
Exclusion criteria: - COVID-19 disease requiring the use of suplemental oxygen - Electrocardiogram (ECG) tracing with QTc interval > 450 ms for men, > 470 ms for women (Fridericia algorithm recommended) - Bradycardia (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Change from baseline in nasopharyngeal SARS-CoV-2 viral load on Day 3 (if quantitative PCR is available) - Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load - Number of participants by PCR result status (positive or negative) - Number of participants with COVID-19 symptoms by severity - Time to resolution of COVID-19 symptoms - Time to resolution of fever - Percentage of participants with resolution of fever - Percentage of participants hospitalized - Number of participants with adverse events | — |
Countries
Netherlands
Outcome results
None listed